Senior Plant Engineer Pharmaceutical

Company: Grimaldi Staffing Services
Location: Fremont
Posted on: August 6, 2022

Job Description:

As Process Engineer, Sr Process Engineer in a pharmaceutical GMP environment, you will participates in design review and implementation for all projects, process engineering, refurbishment/replacement and life cycle cost analysis for the Drug Substance/Drug Product process and equipment. Leveraging your background in Chemical or Mechanical engineering, you will provide engineering support for drug substance related maintenance, engineering and calibration management programs. This position troubleshoots operations of the process & facilities equipment and utilities as needed. You will develop, establish and maintain quality-engineering methodologies, systems, and practices which meet internal and regulatory requirements. You will also provide focused quality engineering support for the Facilities department on new construction, facility upgrades/retrofits/modernizations, and facilities equipment.Essential Duties/Responsibilities

• Perform design review and construction management for projects
• Perform in-house design and manages facilities engineering and construction projects
• Manage the installation and repair of infrastructure of Drug substance and Drug product process equipment as well as related environments. This includes fillers, cappers, Lyophilizers, closed RABs, vial washers, inspection and labeling equipment
• Support the installation, maintenance, operation, and adjustments made to the process equipment, and related utilities such as pumps, boilers, air handling units, air compressors, chillers, clean steam, and USP Purified Water systems
• Collaborate with manufacturing departments to ensure compliance activities are executed efficiently and effectively, and in accordance with all governing documents and regulatory guidelines
• Serve as a subject matter expert (SME) in support of drug substance and drug product related facilities equipment and projects
• Develop, mentor, and train personnel and internal customers on relevant business processes
• Contribute to continuous quality improvement efforts to conform to regulatory requirements and industry standards.
• Track, trend and analyze utility data
• Support negotiations and management of technical facility maintenance contracts
• Support management and oversight of scheduled preventative maintenance on a wide variety of process equipment and support utilities
• Cross Train in-house staff on facilities and process equipment operation & maintenance
• Perform related duties of a similar nature and complexity as required
• Liaison between engineering, manufacturing and quality to identifying and resolving quality and compliance related issues
• Identifies and implements effective commissioning and validation, and support the development, qualification, and ongoing quality support of facilities to meet or exceed internal and external requirements
• Act as an effective team member in supporting quality disciplines, decisions, and practices
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
• Assure the development and execution of streamlined quality systems for the team, which effectively identify and resolve quality issuesEducationB.S. in Related Chemical Engineering or Mechanical Engineering preferredExperience
  • HVAC and clean utilities design or installation experience
  • required to occasionally wear personal protective equipment including respiratory protection equipment
  • Aseptic formulation and filling manufacturing experience required
  • Working with Fermenters and Lyophilizers
  • IMA branded equipment preferred
  • Biosafety cabinets
  • Ability to work independently and cross-functionally in a dynamic environment
  • Ability to draft, edit and complete required qualification and engineering documentsKnowledge, Skills and Abilities
    • Must have working knowledge of biological processes, equipment, and facilities. Experience with potent compounds or CDC Select Agent and Toxin regulations a plus
    • A minimum of 7 years' experience in a GMP regulated environment
    • Must have exceptional written and oral communication skills
    • Must be familiar with the Microsoft Office suite of products

Keywords: Grimaldi Staffing Services, Fremont , Senior Plant Engineer Pharmaceutical, Professions , Fremont, California